510(k) · Cleared
ClearedMethadone Enzyme Immunoassay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lin-Zhi International, Inc. · DJR Enzyme Immunoassay, Methadone
Cleared on Dec 12, 2002 as substantially equivalent to K972526 (Diagnostic Reagents, Inc., 1997) after a 70-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Dec 12, 2002
- Review
- 70 days
- Class
- Class II
- Product code
- DJR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972526 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK972526 Methadone Eia AssayDiagnostic Reagents, Inc. · 1997
- This deviceK023317 Methadone Enzyme ImmunoassayLin-Zhi International, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK192433 LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK033885 BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit)Lin-Zhi International, Inc. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972526 | Methadone Eia Assay | Diagnostic Reagents, Inc. | 1997 | — |
| 0 (this device) | K023317 | Methadone Enzyme Immunoassay | Lin-Zhi International, Inc. | 2002 | — |
| +1 | K192433 | LZI Methadone II Enzyme Immunoassay | Lin-Zhi International, Inc. | 2019 | — |
| +1 | K033885 | BMBP Enzyme Immunoassay, Cat #0610, 0611 (500, 5000 Test Kit) | Lin-Zhi International, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DJR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972526 | Methadone Eia AssaySummary page 1…nal, Inc. ’ Methadone Enzyme Immunoassay is substantially equivalent to the Methadone Enzyme Immunoassay (By DRIhficrogenics Corp.), cleared under premarket notification K972526. LZI’s Methadone Enzyme Immunoassay is identical or similar to its predicate in terms of intended use, method principle, device… | 1997 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K192433 (Lin-Zhi International, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All DJR devicesDJR Enzyme Immunoassay, Methadone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DJR
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · DJR
59in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DJR
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DJR
1in 2025
MAUDE reports naming product code DJR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 2 | 0 |
| 2009 | 1 | — | 1 | 0 |
| 2010 | 3 | 469 | 1 | 3 |
| 2011 | 0 | — | 0 | 6 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 3 | 59 | 0 | 2 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Methadone Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of methadone in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. The Methadone Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a…
Read the full statement (101 words)
The Methadone Enzyme Immunoassay is a homogeneous enzyme immunoassay with a 300 ng/mL cutoff. The assay is intended for use in the qualitative and semi-quantitative analyses of methadone in human urine. The assay is designed for professional use with a number of automated clinical chemistry analyzers.
The Methadone Enzyme Immunoassay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatogaphy/mass spectrometry (GUMS) is the preferred confirmatory method. Clinical consideration and professional judgement should be applied to any drug-of-abuse test result, particularly when preliminary positive results are used.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023317 · printed Nov 4, 2026
Cite this page
510(k) Report. “K023317: Methadone Enzyme Immunoassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K023317
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026